Trial Profile
A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency
Status:
Active, no longer recruiting
Phase of Trial:
Phase II
Latest Information Update: 19 Sep 2023
Price :
$35
*
At a glance
- Drugs Mitapivat (Primary) ; Mitapivat (Primary)
- Indications Haemolytic anaemia; Pyruvate kinase deficiency of red cells
- Focus Adverse reactions; Proof of concept
- Acronyms DRIVE PK
- Sponsors Agios Pharmaceuticals
- 05 Sep 2023 Planned End Date changed from 1 May 2025 to 1 Mar 2025.
- 15 Jun 2023 Results assessing changes in Hb and hemolysis after mitapivat treatment in adult pts with PK deficiency and baseline Hb>10 g/dL who were not regularly transfused and enrolled in the DRIVE-PK and ACTIVATE/LTE of presented at the 28th Congress of the European Haematology Association
- 17 Jun 2022 Results (n=90; data cut-off 4 Mar 2021) assessing bone mineral density over time in a broad pyruvate kinase deficiency population (independent of transfusion) receiving long-term treatment with mitapivat in patients enrolled from DRIVE-PK (NCT02476916), ACTIVATE (NCT03548220), ACTIVATE-T (NCT03559699), and the long-term extension (LTE) of ACTIVATE and ACTIVATE-T (NCT03853798), presented at the 27th Congress of the European Haematology Association.